Sterile Purified Water
[Note—For microbiological guidance, see Water for Pharmaceutical Purposes 1231. ]

H2O
18.02
DEFINITION
Sterile Purified Water is Purified Water sterilized and suitably packaged. It contains no antimicrobial agents. [Note—Do not use Sterile Purified Water in preparations intended for parenteral administration. For such purposes use Water for Injection, Bacteriostatic Water for Injection, or Sterile Water for Injection. ]
SPECIFIC TESTS
•  Oxidizable Substances
Sample:  100 mL
Analysis:  Add 10 mL of 2 N sulfuric acid, and heat to a boil. For Sterile Purified Water in containers having a fill volume of less than 50 mL, add 0.4 mL of 0.02 M potassium permanganate, and boil for 5 min; where the fill volume is 50 mL or more, add 0.2 mL of 0.02 M potassium permanganate, and boil for 5 min. If a precipitate forms, cool in an ice bath to room temperature, and pass through a sintered-glass filter.
Acceptance criteria:  The pink color does not completely disappear. Alternatively, perform the test for Total Organic Carbon 643, Sterile Water.
•  Total Organic Carbon, Sterile Water 643: Meets the requirements. Alternatively, perform the test for Oxidizable Substances.
•  Water Conductivity, Sterile Water 645: Meets the requirements
•  Sterility Tests 71: Meets the requirements
ADDITIONAL REQUIREMENTS
•  Packaging and Storage: Preserve in suitable tight containers.
•  Labeling: Label it to indicate the method for preparation and to indicate that it is not for parenteral administration.
Add the following:
•  USP Reference Standards 11
USP 1,4-Benzoquinone RS Click to View Structure
USP Sucrose RS Click to View Structure (ERR 1-Oct-2014)
Auxiliary Information— Please check for your question in the FAQs before contacting USP.
Topic/Question Contact Expert Committee
Monograph Antonio Hernandez-Cardoso, M.Sc.
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(301) 816-8308
(GCCA2010) General Chapters - Chemical Analysis
71 Radhakrishna S Tirumalai, Ph.D.
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(GCM2010) General Chapters - Microbiology
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USP38–NF33 Page 5807
Pharmacopeial Forum: Volume No. 38(3)